Evaluation of Shell Technique for Reconstruction of Alveolar Cleft: Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- October 6 University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Volumetric bone gain
Study Overview
Brief Summary
This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with alveolar ridge cleft
- •Males and females 7-14 years of age.
- •Patients with adequate oral hygiene.
- •Compliance with all requirements in the study and signing the informed consent.
Exclusion Criteria
- •Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%).
- •Patients with systemic disease affecting bone healing.
- •Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications).
- •Patients with history of intravenous and/or oral bisphosphonate use.
- •Pathologic lesions or acute infection in the area of defect.
- •Patients with poor oral hygiene that are not amenable to motivation and improvement.
- •8. Vulnerable patients.
Arms & Interventions
study group
This study group contains of patient who had alveolar cleft, indicated for late secondary alveolar grafting
Intervention: Alveolar ridge grafting (Procedure)
Outcomes
Primary Outcomes
Volumetric bone gain
Time Frame: 4 months
bone volumetric gain and changes measured by CBCT analysis
Secondary Outcomes
- Eruption of the tooth in the cleft(6-9 months)
Investigators
Khalid Tarek Mohamed Karkar
Priniciple investigator
Ministry of Health, Kuwait